Betrnet Stem Cells and the Origins of Barrett's Esophagus Project 3 RF Ablation

NCT ID: NCT01568723

Last Updated: 2021-12-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

125 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-01-31

Study Completion Date

2018-08-16

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to determine biomarkers which can predict response to ablation therapy in patients with Barretts esophagus.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This Project is designed to identify biologically-based and clinically-useful biomarkers of tissue at risk for neoplastic progression as well as of response to ablation therapy. These results will result in improved risk stratification in BE and better targeting of resources for patients who are candidates for ablative therapy, while simultaneously providing key information regarding the origins of Barrett's esophagus.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Barrett's Esophagus

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Barrett's esophagus high grade dysplasia ablation radiofrequency ablation esophageal cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Radiofrequency ablation

participants with barrett's esophagus with high grade dysplasia who undergo radiofrequency ablation (RFA)

response to therapy

Intervention Type GENETIC

evaluate specific markers for response to therapy at specific intervals pre and post therapy

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

response to therapy

evaluate specific markers for response to therapy at specific intervals pre and post therapy

Intervention Type GENETIC

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Barrett's esophagus with high grade dysplasia or intramucosal (early) adenocarcinoma.
* BE length ≥ 2 cm and ≤ 8 cm.
* Able to return every 3 months for one year after ablation

Exclusion Criteria

* Patients who are unable to be compliant with follow-up endoscopies
* patients who cannot tolerate Proton Pump inhibitors
* pre-existing esophageal strictures
* pregnant or nursing women
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Kenneth K. Wang

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Kenneth K Wang, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Columbia University

New York, New York, United States

Site Status

University of Pennsylvania Perelman School of Medicine

Philadelphia, Pennsylvania, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Related Links

Access external resources that provide additional context or updates about the study.

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

U54CA163004

Identifier Type: NIH

Identifier Source: secondary_id

View Link

11-006510

Identifier Type: -

Identifier Source: org_study_id